NCT07060976

To Check Dermatological Safety of Test Products by 24 Hours Patch Testing

Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test Under Complete Occlusion | Semi Occlusion |Open Patch on Adult Healthy Human Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Novamed Laboratories Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To Check Dermatological Safety of Test Products by 24 Hours Patch Testing

Detailed description

This is single center, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion \|Semi occlusion \|Open patch for at least 24 hours (+ 2 hours). Study can be conducted in multiple groups. Safety will be assessed throughout the study by monitoring of adverse events. Subject's back i.e. between the scapula and waist will be utilized as application sites. Application sites will be evaluated for scoring the reaction, namely, erythema, dryness, and wrinkles on a 0-4 point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale after 30+5 minutes of patch removal, 24±2 hours and 168±2 hours after patch removal.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
OTHER	18 Transdermal patches along with positive and negative controls 1)Capsaicin0.025% Topical Patch, 2)Diclofenac Diethylamine 100mg Transdermal Patch, 3)Diclofenac Diethylamine 200mg Transdermal Patch,	Dose: 1×1 cm of each Patch (1 cm2) Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 24 hours. At 24 hours post-application, patches will be removed and skin will be evaluated for irritation reactions at 30 mins,24 hours (Day 1)post patch removal and 168 hours (Day 7) post-patch removal (if needed). Frequency: single application

Timeline

• Start date: 2025-07-21
• Primary completion: 2025-07-29
• Completion: 2025-07-29
• First posted: 2025-07-11
• Last updated: 2025-09-17

Locations

1 site across 1 country: India